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P303 The efficacy of total enteral nutrition in inducing remission and improving nutritional status in children with moderate to severe Crohn's disease
S130 Conclusions: In moderate-to-severe CD patients who failed previous TNF antagonist(s), IV UST induction significantly improved HRQOL vs PBO. During maintenance with SC UST, significant improvement in HRQOL in responders to induction was maintained through wk22. P301 Short-term effectiveness and impact on quality of life of iron carboxymaltose in the treatment of iron deficiency anemia associated with inflammatory bowel disease M.P. Soto-Escribano1 *, V. García S´ anchez1 , E. Iglesias Flores2 , 1 ´ alez-Galilea1 , F. G´ omez J.M. Benítez-Cantero , A. Gonz´ Camacho1 . 1 Reina Sofia Hospital, Digestive Unit, Cordoba, Spain, 2 Reina Sofia Hospital, Cordoba, Spain Background: Iron carboxylmaltose (FeCM) has proved effective and safe in the treatment of iron deficiency anemia, but there are few data on short-term efficacy and the impact on quality of life (QoL) in patients with inflammatory bowel disease (IBD). Therefore, the objectives of this study were to describe the response to treatment with FeCM assessing their short-term efficacy, safety and impact on QoL in patients with IBD and iron deficiency anemia, and to identify possible predictors of therapeutic response. Methods: We included 30 patients with IBD and iron deficiency anemia who were treated with FeCM during the months of May 2010 and May 2011. We collected clinical and laboratory variables at baseline and one month after treatment. The disease activity was assessed by Truelove-Witts index in ulcerative colitis (UC) and the Harvey Bradshaw in Crohn’s disease (CD). Response was assessed at one month, considering therapeutic response the rise of >2 g/dl baseline hemoglobin (Hb). The impact on QoL was assessed using the questionnaire IBDQ-9 before and one month after treatment. Side effects were recorded by telephone survey at week of the infusion. Results: The mean age was 38.6 years (±14.3) and 66.7% (20) were women. 63.3% (19) of patients had CD and 36.7% had UC. The mean disease duration was 82.5 months (±86). At baseline, 60% were in remission or with mild clinical activity. The mean Hb level at baseline was 9.9 g/dl (±0.9) and one month after treatment was 12.2 g/dl (±1.1). The global average rise after treatment was 2.2 g/dl (95% CI 2.7 1.8 p < 0.05) and the overall response was 80% (24). The questionnaires IBDQ-9 pre-and posttreatment showed a significant improvement on QoL with an average difference of 6.1 (95% CI 8.6 3.5 p < 0.05). Side effects appeared in 13.3% (4), all of them were mild. Predictors of response to treatment were not identified. Conclusions: The FeCM is effective and safe in the treatment of iron deficiency anemia associated with IBD reaching a early response and improving the QoL of patients. P302 The impact of induction and maintenance therapy with infliximab on mucosal healing and clinical remission in Polish pediatric patients with moderate to severe Crohn’s disease J. Kierkus1 *, E. Szymanska1 , M. Dadalski1 , A. Wegner1 , G. Oracz1 , M. Gorczewska1 , S. Szymanska1 , M. Woynarowski1 , J. Ryzko1 . 1 The Children’s Memorial Health Institute, Warsaw, Poland Background: Infliximab (IFX) is currently registered for use in Crohn’s disease (CD) in children over 7 years of age. Healing of mucosal lesions seems to be most important end point of the successful therapy with biological agents. The aim of this study was to assess clinical efficacy and the impact of induction therapy with three doses of IFX on mucosal healing in children with CD and to assess the benefit of maintenance therapy with IFX in paediatric patients with active Crohn’s disease who responded to induction therapy with 3 doses of infliximab.
Poster presentations Methods: 66 children aged 14.06; 12.9; 16.3 [median; Q1; Q3] with moderate to severely active Crohn’s Disease were included into the study. Patients received infliximab (5 mg/kg) in three repeated infusions at 0, 2, 6 weeks. The disease clinical activity was assessed by (PCDAI) and endoscopic activity was scored using the Simple Endoscopic Score (SES-CD) at baseline and at week 10. Those patients who have achieved the remission at week 10 (n = 32) were qualified to the maintenance therapy with repeat 5 mg/kg infliximab every 8 weeks. The PCDAI and the SES-CD together with laboratory tests were performed at week 10 and 50. Results: Induction therapy: 22 (33%) of patients have reached clinical remission, 26 (39%) had clinical response. The significant decreases (p < 0.05) in PCDAI [median; Q1; Q3]: 52.5; 45.0; 57.5 vs. 15.0; 10.0; 30.0; CRP: 1.6; 0.3; 3.5 vs. 0.3; 0.2; 2.1, platelets level 368.0; 287.0; 506.0 vs. 309.0; 263.0; 459.0 and significant increase in BMI: 17.5; 15.4; 19;4 vs. 18.0; 16.7; 20.0 were found when data from baseline and week 10 were compared. Significant decrease in SES-CD score (p < 0.05) [median; Q1; Q3] between initial and control colonoscopy (18; 12; 22 vs 7.5; 1; 15.0) was observed. Maintenance therapy: 14 (44%) patients has reached clinical remission (defined as PCDAI score 10) at week 10 and 23 (72%) at week 50 after the whole maintenance therapy. We have found no significant decrease in SES-CD score 3.5 (0.0; 10.0) vs 4.0 (0.0; 7.5) (median; Q1; Q3). p > 0.05, between initial and control colonoscopy. Conclusions: Biological therapy with infliximab allows to achieve mucosal healing in pediatric patients with Crohn’s disease. Induction therapy with infliximab was clinically effective in 72% pediatric patients with Crohn’s disease. Maintenance therapy with infliximab is efficient in maintening remission of disease and mucosal healing. P303 The efficacy of total enteral nutrition in inducing remission and improving nutritional status in children with moderate to severe Crohn’s disease J. Kierkus1 *, S. Szymanska1 , M. Szczepanski1 , A. Janowska1 , M. Matuszczyk1 , E. Szymanska1 , J. Ryzko1 . 1 The Children’s Memorial Health Institute, Warsaw, Poland Background: Growth retardation and malnutrition is a very common complication of Crohn’s disease (CD) in children. Total enteral nutrition (TEN) is one of a treatment’s options in active disease. The aim of this study was to assess the efficacy of TEN for inducing remission in children with active CD in comparison to conventional steroid therapy. Methods: The study consisted of twenty children with active Crohn’s disease. All patients were placed on a TEN regiment in hospital and next at home. It was continue 6 weeks. Children were examined at the time of recruitment and after two weeks of treatment. Those who reached the remission (n = 8) were followed up for next 12 months. Clinical condition, anthropometric measurements and blood tests were analyzed. The control group consisted of 24 children with active CD treated with conventional steroid therapy. Results: Remission was achieved in 40% of patients on enteral nutrition and 45.8% on steroid therapy, respectively. The duration of remission lasted 7.75±3.2 months in studied group and 8.5±2.48 months in CG, respectively. In both groups duration of remission was 12 months at most. There was a significant increase in weight (+5.7 kg), weight for height SDS (+0.6), and LBM (+4.8 kg) (p < 0.05) in studied group. For laboratory parameters significant rise in haemoglobin, erythrocytes and significant reduction in platelet and CRP was observed. There was no significant change in ESR and albumin. In CG significant change was observed only in CRP. Conclusions: TEN is an effective treatment for inducing remission in children with active CD, it can suppress
Clinical: Therapy and observation
S131
gut inflammation and improved growth. Its effectiveness is comparable to conventional steroid therapy.
P305 Predictive factors of one-year mucosal healing in a cohort of ulcerative colitis patients in treatment with infliximab
P304 Cyclosporine or infliximab as rescue therapy in severe refractory ulcerative colitis: Early and long-term data from a retrospective observational study
G. Andrisani1 *, A. Armuzzi2 , C. Felice3 , M. Marzo4 , G. Mocci5 , D. Pugliese6 , I. De Vitis3 , L. Guidi7 , G.L. Rapaccini8 , A. Papa6 . 1 Catholic University of Rome, Internal Medicine Department/Gastroenterology Division, Rome, Italy, 2 Complesso Integrato Columbus, Gastroenterology Unit, Rome, Italy, 3 Universit` a Cattolica Del Sacro Cuore, Complesso integrato Columbus/OU of Internal Medicine and Gastroenterology, Rome, Italy, 4 Complesso Integrato Columbus, Medicina Interna e Gastroenterologia, Rome, Italy, 5 Catholic University of Rome, Internal Medicine Gastroenterology, Rome, Italy, 6 Catholic University of Rome, Internal Medicine and Gastroenterology Complesso Integrato Columbus, Rome, Italy, 7 Universit` a Cattolica Del Sacro Cuore, O.U. Gastroenterology Columbus, Rome, Italy, 8 Catholic University of Rome, Complesso Integrato Columbus/OU of Internal Medicine and Gastroenterology, Rome, Italy
F. Mocciaro1 *, S. Renna2 , A. Orlando3 , G. Rizzuto2 , E. Sinagra4 , E. Orlando5 , M. Cottone6 . 1 V Cervello Hospital, Palermo, Italy, 2 Palermo University, Villa Sofia-V. Cervello Hospital/Department of Medicine, Palermo, Italy, 3 V Cervello Hospital, Istituto di Medicina Generale e Pneumologia Reparto di Medicina Interna, Palermo, Italy, 4 V Cervello Hospital, Palermo University/Department of Medicine Pneumology and Physiology of Nutrition, Palermo, Italy, 5 Palermo University, Italy, 6 V Cervello Hospital, Instituto di Medicina Generale e Pneumologia, Palermo, Italy Background: Acute severe ulcerative colitis (UC) is a dangerous clinical condition that requires intensive intravenous (iv) corticosteroid treatment, nevertheless about 30 40% of patients fail to respond. Iv cyclosporine and infliximab are an effective rescue therapy in steroid-refractory UC patients but up to now it is still unclear which is the best therapeutic choice in this setting of patients. Methods: We reviewed our series of severe (according to Trulove and Witts, and Lichtiger score) steroid-refractory colitis admitted consecutively from 1994 up to today comparing patients treated with cyclosporine (2 mg/kg daily) or infliximab (5 mg/kg). Iv steroid treatment was administered according to the “Oxford regimen”. The main outcome was the colectomy rate at 3 months, 12 months and at the end of the follow-up. Results: A total of 65 patients were evaluated: 35 in the cyclosporine group and 30 in the infliximab one. The patients’ characteristics in the two groups were comparable. After 3 months from the acute episode the colectomy rate was: 28.5% (10/35) in cyclosporine group and 17% (5/30) in infliximab group (p = 0.25). At 12 months the rate of colectomy increased to 48% in cyclosporine group versus 17% in infliximab group (p = 0.007, OR 4.7; 95% CI: 1.47 15.16). The 1 2-3 years cumulative colectomy rates were 48%, 54%, and 57% in cyclosporine group, and 17%, 23%, and 27% in infliximab group. At the end of the follow-up the colectomy rate was: 60% in cyclosporine group and 30% in infliximab group (p = 0.04, HR 2.2; 95% CI: 1.11 4.86). No difference was observed regarding the risk of re-hospitalization at 12 months (p = 0.3, OR 0.2; 95% CI 0.532 5.805) and during the follow-up (p = 0.7, HR 1.13; 95% CI: 0.48 2.63). High level of C reactive protein (p = 0.04, OR 2.9; 95% CI: 1.18 8.28), extensive disease (p = 0.01, OR 5.5; 95% CI: 1.57 19.01) and no azathioprine treatment after the rescue therapy (p < 0.001, OR 8.7; 95% CI: 2.49 30.12) were related to the risk of colectomy. No differences in terms of side effects were observed between the two groups and no serious adverse events were recorded. Conclusions: In our experience both cyclosporine and infliximab are effective in avoiding colectomy in severe steroid-refractory UC. During the follow-up the risk of colectomy is higher in those treated with cyclosporine than with infliximab. High level CRP, extensive disease and no azathioprine treatment were related to the risk of colectomy. Both the drugs were equally safe without severe adverse events.
Background: Recent studies have shown that in patients with ulcerative colitis (UC) the mucosal healing (MH) is a reliable marker of response to biological therapy with important prognostic implications, including long-term remission and colectomy-rate. However, the factors that determine the achievement of the MH in UC patients treated with the antiTNF-a agent infliximab (IFX) are poorly defined. The aim of this study was to assess in a cohort of consecutive patients with UC treated with IFX the factors associated with the achievement of MH after one-year of therapy. Methods: All consecutive patients with UC treated for one-year with scheduled infusions of IFX and who underwent colonoscopy before starting therapy and after one year (±3 months) were enrolled in the study. To assess the endoscopic activity of disease was used the Mayo score. MH was defined as a Mayo score of 0 or 1. Clinical features of each patients and the concomitant therapies assumed by the patients were recorded at baseline and after one-year. Changes in the dosage of the drugs (or the reduction in the interval time between two consecutive infusions of IFX) or the introduction of immunosuppressors during the study period were also recorded. Results: Thirty-five patients were included in the study overall (mean age 43.9±15.2 years, 22 females (62.8%). Twenty patients (57%) were treated with IFX for steroid-dependence, 10 (28.5%) for refractoriness to steroids, 5 for extraintestinal manifestations. Nineteen patients (54%) reached MH at one-year. At univariate analysis discontinuation of steroids (p = 0.02), the concomitant use of immunosuppressors (p = 0.05) and CRP-levels 5 mg/L (p = 0.05) at baseline were associated with MH. At multivariate analysis only steroids discontinuation (p = 0.05) was significantly associated with MH at one-year. Conclusions: The results of the present study show that in a population of UC patients the discontinuation of steroids is significantly associated with MH after one year of treatment with IFX. However, confirmation of this outcome needs more studies on large populations of patients with UC in treatment with IFX.
Poster presentations Methods: 66 children aged 14.06; 12.9; 16.3 [median; Q1; Q3] with moderate to severely active Crohn’s Disease were included into the study. Patients received infliximab (5 mg/kg) in three repeated infusions at 0, 2, 6 weeks. The disease clinical activity was assessed by (PCDAI) and endoscopic activity was scored using the Simple Endoscopic Score (SES-CD) at baseline and at week 10. Those patients who have achieved the remission at week 10 (n = 32) were qualified to the maintenance therapy with repeat 5 mg/kg infliximab every 8 weeks. The PCDAI and the SES-CD together with laboratory tests were performed at week 10 and 50. Results: Induction therapy: 22 (33%) of patients have reached clinical remission, 26 (39%) had clinical response. The significant decreases (p < 0.05) in PCDAI [median; Q1; Q3]: 52.5; 45.0; 57.5 vs. 15.0; 10.0; 30.0; CRP: 1.6; 0.3; 3.5 vs. 0.3; 0.2; 2.1, platelets level 368.0; 287.0; 506.0 vs. 309.0; 263.0; 459.0 and significant increase in BMI: 17.5; 15.4; 19;4 vs. 18.0; 16.7; 20.0 were found when data from baseline and week 10 were compared. Significant decrease in SES-CD score (p < 0.05) [median; Q1; Q3] between initial and control colonoscopy (18; 12; 22 vs 7.5; 1; 15.0) was observed. Maintenance therapy: 14 (44%) patients has reached clinical remission (defined as PCDAI score 10) at week 10 and 23 (72%) at week 50 after the whole maintenance therapy. We have found no significant decrease in SES-CD score 3.5 (0.0; 10.0) vs 4.0 (0.0; 7.5) (median; Q1; Q3). p > 0.05, between initial and control colonoscopy. Conclusions: Biological therapy with infliximab allows to achieve mucosal healing in pediatric patients with Crohn’s disease. Induction therapy with infliximab was clinically effective in 72% pediatric patients with Crohn’s disease. Maintenance therapy with infliximab is efficient in maintening remission of disease and mucosal healing. P303 The efficacy of total enteral nutrition in inducing remission and improving nutritional status in children with moderate to severe Crohn’s disease J. Kierkus1 *, S. Szymanska1 , M. Szczepanski1 , A. Janowska1 , M. Matuszczyk1 , E. Szymanska1 , J. Ryzko1 . 1 The Children’s Memorial Health Institute, Warsaw, Poland Background: Growth retardation and malnutrition is a very common complication of Crohn’s disease (CD) in children. Total enteral nutrition (TEN) is one of a treatment’s options in active disease. The aim of this study was to assess the efficacy of TEN for inducing remission in children with active CD in comparison to conventional steroid therapy. Methods: The study consisted of twenty children with active Crohn’s disease. All patients were placed on a TEN regiment in hospital and next at home. It was continue 6 weeks. Children were examined at the time of recruitment and after two weeks of treatment. Those who reached the remission (n = 8) were followed up for next 12 months. Clinical condition, anthropometric measurements and blood tests were analyzed. The control group consisted of 24 children with active CD treated with conventional steroid therapy. Results: Remission was achieved in 40% of patients on enteral nutrition and 45.8% on steroid therapy, respectively. The duration of remission lasted 7.75±3.2 months in studied group and 8.5±2.48 months in CG, respectively. In both groups duration of remission was 12 months at most. There was a significant increase in weight (+5.7 kg), weight for height SDS (+0.6), and LBM (+4.8 kg) (p < 0.05) in studied group. For laboratory parameters significant rise in haemoglobin, erythrocytes and significant reduction in platelet and CRP was observed. There was no significant change in ESR and albumin. In CG significant change was observed only in CRP. Conclusions: TEN is an effective treatment for inducing remission in children with active CD, it can suppress
Clinical: Therapy and observation
S131
gut inflammation and improved growth. Its effectiveness is comparable to conventional steroid therapy.
P305 Predictive factors of one-year mucosal healing in a cohort of ulcerative colitis patients in treatment with infliximab
P304 Cyclosporine or infliximab as rescue therapy in severe refractory ulcerative colitis: Early and long-term data from a retrospective observational study
G. Andrisani1 *, A. Armuzzi2 , C. Felice3 , M. Marzo4 , G. Mocci5 , D. Pugliese6 , I. De Vitis3 , L. Guidi7 , G.L. Rapaccini8 , A. Papa6 . 1 Catholic University of Rome, Internal Medicine Department/Gastroenterology Division, Rome, Italy, 2 Complesso Integrato Columbus, Gastroenterology Unit, Rome, Italy, 3 Universit` a Cattolica Del Sacro Cuore, Complesso integrato Columbus/OU of Internal Medicine and Gastroenterology, Rome, Italy, 4 Complesso Integrato Columbus, Medicina Interna e Gastroenterologia, Rome, Italy, 5 Catholic University of Rome, Internal Medicine Gastroenterology, Rome, Italy, 6 Catholic University of Rome, Internal Medicine and Gastroenterology Complesso Integrato Columbus, Rome, Italy, 7 Universit` a Cattolica Del Sacro Cuore, O.U. Gastroenterology Columbus, Rome, Italy, 8 Catholic University of Rome, Complesso Integrato Columbus/OU of Internal Medicine and Gastroenterology, Rome, Italy
F. Mocciaro1 *, S. Renna2 , A. Orlando3 , G. Rizzuto2 , E. Sinagra4 , E. Orlando5 , M. Cottone6 . 1 V Cervello Hospital, Palermo, Italy, 2 Palermo University, Villa Sofia-V. Cervello Hospital/Department of Medicine, Palermo, Italy, 3 V Cervello Hospital, Istituto di Medicina Generale e Pneumologia Reparto di Medicina Interna, Palermo, Italy, 4 V Cervello Hospital, Palermo University/Department of Medicine Pneumology and Physiology of Nutrition, Palermo, Italy, 5 Palermo University, Italy, 6 V Cervello Hospital, Instituto di Medicina Generale e Pneumologia, Palermo, Italy Background: Acute severe ulcerative colitis (UC) is a dangerous clinical condition that requires intensive intravenous (iv) corticosteroid treatment, nevertheless about 30 40% of patients fail to respond. Iv cyclosporine and infliximab are an effective rescue therapy in steroid-refractory UC patients but up to now it is still unclear which is the best therapeutic choice in this setting of patients. Methods: We reviewed our series of severe (according to Trulove and Witts, and Lichtiger score) steroid-refractory colitis admitted consecutively from 1994 up to today comparing patients treated with cyclosporine (2 mg/kg daily) or infliximab (5 mg/kg). Iv steroid treatment was administered according to the “Oxford regimen”. The main outcome was the colectomy rate at 3 months, 12 months and at the end of the follow-up. Results: A total of 65 patients were evaluated: 35 in the cyclosporine group and 30 in the infliximab one. The patients’ characteristics in the two groups were comparable. After 3 months from the acute episode the colectomy rate was: 28.5% (10/35) in cyclosporine group and 17% (5/30) in infliximab group (p = 0.25). At 12 months the rate of colectomy increased to 48% in cyclosporine group versus 17% in infliximab group (p = 0.007, OR 4.7; 95% CI: 1.47 15.16). The 1 2-3 years cumulative colectomy rates were 48%, 54%, and 57% in cyclosporine group, and 17%, 23%, and 27% in infliximab group. At the end of the follow-up the colectomy rate was: 60% in cyclosporine group and 30% in infliximab group (p = 0.04, HR 2.2; 95% CI: 1.11 4.86). No difference was observed regarding the risk of re-hospitalization at 12 months (p = 0.3, OR 0.2; 95% CI 0.532 5.805) and during the follow-up (p = 0.7, HR 1.13; 95% CI: 0.48 2.63). High level of C reactive protein (p = 0.04, OR 2.9; 95% CI: 1.18 8.28), extensive disease (p = 0.01, OR 5.5; 95% CI: 1.57 19.01) and no azathioprine treatment after the rescue therapy (p < 0.001, OR 8.7; 95% CI: 2.49 30.12) were related to the risk of colectomy. No differences in terms of side effects were observed between the two groups and no serious adverse events were recorded. Conclusions: In our experience both cyclosporine and infliximab are effective in avoiding colectomy in severe steroid-refractory UC. During the follow-up the risk of colectomy is higher in those treated with cyclosporine than with infliximab. High level CRP, extensive disease and no azathioprine treatment were related to the risk of colectomy. Both the drugs were equally safe without severe adverse events.
Background: Recent studies have shown that in patients with ulcerative colitis (UC) the mucosal healing (MH) is a reliable marker of response to biological therapy with important prognostic implications, including long-term remission and colectomy-rate. However, the factors that determine the achievement of the MH in UC patients treated with the antiTNF-a agent infliximab (IFX) are poorly defined. The aim of this study was to assess in a cohort of consecutive patients with UC treated with IFX the factors associated with the achievement of MH after one-year of therapy. Methods: All consecutive patients with UC treated for one-year with scheduled infusions of IFX and who underwent colonoscopy before starting therapy and after one year (±3 months) were enrolled in the study. To assess the endoscopic activity of disease was used the Mayo score. MH was defined as a Mayo score of 0 or 1. Clinical features of each patients and the concomitant therapies assumed by the patients were recorded at baseline and after one-year. Changes in the dosage of the drugs (or the reduction in the interval time between two consecutive infusions of IFX) or the introduction of immunosuppressors during the study period were also recorded. Results: Thirty-five patients were included in the study overall (mean age 43.9±15.2 years, 22 females (62.8%). Twenty patients (57%) were treated with IFX for steroid-dependence, 10 (28.5%) for refractoriness to steroids, 5 for extraintestinal manifestations. Nineteen patients (54%) reached MH at one-year. At univariate analysis discontinuation of steroids (p = 0.02), the concomitant use of immunosuppressors (p = 0.05) and CRP-levels 5 mg/L (p = 0.05) at baseline were associated with MH. At multivariate analysis only steroids discontinuation (p = 0.05) was significantly associated with MH at one-year. Conclusions: The results of the present study show that in a population of UC patients the discontinuation of steroids is significantly associated with MH after one year of treatment with IFX. However, confirmation of this outcome needs more studies on large populations of patients with UC in treatment with IFX.